483 >It likely means the 483 observation is focused on scaling issues. For example, there could be some manual process now in place that is satisfactory for current low volumes, but either this manual process would not be compliant at higher volumes, or DNDN's proposed automated process is not viewed as compliant. I'm talking about some inventory control, or QA sampling, or lot management process for example.
But the fundamental manufacturing processes themselves are apparently not being challenged by FDA, since trial production continues.<
Yes it could be scale up.
Your comment in #msg-20321963 "Best case may be that the 483 was focused on Electronic Records and Signatures issues. Over the past 10 years ERS has evolved hugely with FDA (just google '21 cfr part 11') and it can be relatively easy pickens for inspectors, both because it is a new area and compliance complex to understand. But fixes can be easy, focused on procedural changes, documentation, or even training."
It is critically important that they can track what cells came from which patient, and put the primed immune cells back in the correct patient, otherwise you could get an immune response (or even a GVHD type reaction.) Proper paperwork and tracking would be key.
It's an idle thought. I doubt we'll find out what the problem is if they resolve in a timely fashion. If they don't, it may come out in court.
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